Novartis announced results from a Phase 3 trial for Signifor LAR (pasireotide LAR; SOM230) in patients with acromegaly for whom current standard of care provides inadequate disease control.

The trial was a multicenter, randomized, double-blind trial examining pasireotide LAR 40mg or 60mg vs. continued open-label treatment with octreotide LAR 30mg or lanreotide Autogel 120mg (the control group) for 24 weeks. The trial included 198 patients with inadequately controlled acromegaly on maximum approved doses of octreotide LAR or lanreotide Autogel for at least 6 months, regardless of prior surgical status. The primary endpoint of this study was the proportion of patients achieving biochemical control as measured by the mean GH levels of <2.5μg/L and normalized IGF-1 at 24 weeks.

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Patients taking pasireotide long-acting release (LAR) achieved greater disease control when compared to continued treatment with the standard somatostatin analogue therapies, octreotide LAR or lanreotide Autogel. IGF-1 normalization was achieved by 24.6% and 26.2% of patients taking pasireotide LAR 40mg and 60mg, respectively (95% CI, 14.8–36.9; P<0.001; 95% CI, 16.0–38.5; P<0.001), and was not achieved by any patients in the control arm (95% CI, 0–5.3). Additionally, 35.4% and 43.1% of patients in the pasireotide LAR 40mg and 60mg arms, respectively (95% CI, 23.9–48.2; 95% CI, 30.8–56.0), had mean GH levels of <2.5μg/L compared to 13.2% in the control arm (95% CI, 6.2–23.6).

Signifor is already approved for the treatment of adult patients with Cushing’s disease for whom pituiraty surgery is not an option or has not been curative.

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